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Re: The ELTP King post# 147

Thursday, 01/16/2020 1:41:41 PM

Thursday, January 16, 2020 1:41:41 PM

Post# of 169
aelmtpa- I guess I will watch where ELTP goes next. That being said, don't celebrate and don't bet the farm on them getting approval. They were already denied at least once before and in general opioid approvals are very hard to come by. I am just a realist. I gave IPCI a 5% chance of approval before everything came to light. You might want to listen to the ADCOM board comments. The standard for approval is a moving target that gets harder and harder each day. FDA past guidance is obsolete and the approval question is do the benefits outweigh the risks? And panel attendees as much said they are evaluating as do the benefits GREATLY outweigh the risks.
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